Transcription of FDA Regulation of Medical Devices
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FDA Regulation of Medical Devices
FDA Regulation of Medical Devices Judith A. Johnson Specialist in Biomedical Policy September 14, 2016 Congressional Research Service 7-5700 R42130 FDA Regulation of Medical Devices Congressional Research Service Summary Prior to and since the passage of the Medical Device Amendments of 1976, Congress has debated how best to ensure that consumers have access, as quickly as possible, to new and improved Medical Devices and, at the same time, prevent Devices that are not safe and effective from entering or remaining on the market. Medical device Regulation is complex, in part, because of the wide variety of items that are categorized as Medical Devices ; examples range from a simple tongue depressor to a life-sustaining heart valve. The Regulation of Medical Devices can affect their cost, quality , and availability in the health care system.
Quality Standards Act (MQSA, P.L. 102-539), and device user fees fund some non–device-specific activities at FDA. 6 Title VI of FDASIA addresses the regulation of medical devices; for further information see CRS Report R42680, The Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144), coordinated by Susan Thaul.
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